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`15349778
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`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
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`|1574
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`Attorney Docket Number |AVN-009DVCN6
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`' ()1 6-09-27
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`azani et al.
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`Application Number 15349778
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`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
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`T5
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`rrata to the Sarepta Briefing Information for the April 25, 2016 Meeting of the Peripheral and Central Nervous System
`Irugs Advisory Committee, Eteplirsen Errata Document, NDA 206488, 5 pages.
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`xon 46 Sequence of Dystrophin, Document D18 as filed in Opposition of European Patent EP1619249, filed June 23,
`'009, 1 page
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`DA Briefing Information for the April 25, 2016 Meeting of the Peripheral and Central Nervous System Drugs Advisory
`ommittee, Eteplirsen, NDA 206488, 115 pages
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`DA News Release, "FDA grants accelerated approval to first drug for Duchenne muscular dystrophy," September 19,
`'016, 3 pages.
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`ett Foundation Presentation by McSherry, C. "Patient and Caregiver—Reported Outcomes of Patients in Clinical Trials
`f Eteplirsen for Treatment of Duchenne" at Peripheral and Central Nervous System Drugs Advisory Committee, April
`'5, 2016, 17 pages.
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`oenig, C. et al., "Alternative splicing of human dystrophin mRNA generates isoforms at the carboxy terminus," Nature
`ol. 338:509 — 511 (1989).
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`etter from the FDA to Sarepta Therapeutics, Inc., Re: ACCELERATED APPROVAL for the use of Exondys 51
`eteplirsen), FDA Reference ID: 3987286, dated September 19, 2016, 11 pages.
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`IN FORMATION DISCLOSU RE
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`Application Number 15349778
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`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
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`Art U .
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`mt
`I 1674
`Examiner Name
`Not Yet Assigned
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` Attorney Docket Number
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`etter to the US. Food and Drug Administration, (Dr. Billy Dunn, MD. Director Division of Neurology Products, Office
`f Drug Evaluation 1, Center for Drug Evaluation and Research), for The Peripheral and Central Nervous System
`dvisory Committee Meeting (AdComm) supporting approval of eteplirsen, dated February 24, 2016, 4 pages.
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`etter to the US. Food and Drug Administration, (Dr. Janet Woodcock, MD. Director, CDER), from The Congress of
`he United States regarding Duchenne muscular dystrophy, dated February 17, 2016, 7 pages.
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`'rescribing Information for EXONDYS 51 (eteplirsen) Injection, dated 09/2016, 10 pages
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`.arepta Briefing Information for the April 25, 2016 Meeting of the Peripheral and Central Nervous System Drugs
`dvisory Committee, Eteplirsen Briefing Document, NDA 206488, 186 pages.
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`.arepta Press Release, Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the
`reatment of Duchenne Muscular Dystrophy, April 25, 2016, 2 pages
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`arepta Therapeutics, Inc. News Release, "Sarepta Therapeutics Announces FDA Accelerated Approval of EXONDY
`.1T" (eteplirsen) injection, an Exon Skipping Therapy to Treat Duchenne Muscular Dystrophy (DMD) Patients
`‘ menable to Skipping Exon 51," September 19, 2016, 2 pages.
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`.3. Food and Drug Administration Presentation at Peripheral and Central Nervous System Drugs Advisory
`ommittee, April 25, 2016, 178 pages.
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`niversity of Western Australia v. Academisch Ziekenhuis Leiden, Decision - Motions — 37 CFR. § 41 .125(a), filed in
`' atent Interference No. 106008, September 20, 2016, pages 1-20 (Doc 480)
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`—l ‘4
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`niversity of Western Australia v. Academisch Ziekenhuis Leiden, Decision - Motions — 37 CFR § 41 .125(a)
`Substitute), filed in Patent Interference No. 106007, May 12, 2016, pages 1-53 (Doc 476)
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`niversity of Western Australia v. Academisch Ziekenhuis Leiden, Judgment - Motions — 37 CFR. § 41.127 filed in
`' atent Interference No. 106008, September 20, 2016, pages 1-3 (Doc 481)
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`Application Number 15349778
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`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`.
`.
`( Not for submissmn under 37 CFR 1.99)
`
`
`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
`
`Art U .
`mt
`I 1674
`
`Examiner Name
`Not Yet Assigned
`
` Attorney Docket Number
`
`niversity of Western Australia v. Academisch Ziekenhuis Leiden, Judgment - Motions — 37 CFR § 41.127, filed in
`' atent Interference No. 106007, April 29, 2016, pages 1-3, (Doc 474)
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`niversity of Western Australia v. Academisch Ziekenhuis Leiden, Redeclaration - 37 CFR 41 .203(c), filed in Patent
`nterference No. 106007, April 29, 2016, pages 1—2, (Doc 473)
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`I AVN-009DVCN6
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`niversity of Western Australia v. Academisch Ziekenhuis Leiden, Withdrawal and Reissue of Decision on Motions,
`fled in Patent Interference No. 106007, May 12,2016, pages 1—2 (Doc 475)
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`niversity of Western Australia v. Academisch Ziekenhuis Leiden, Decision — Motions — 37 CFR § 41 .125(a), filed in
`' atent Interference No. 106007, April 29, 2016, pages 1-53, (Doc 472)
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`xtended European Search Report, EP 151903416, dated April 28, 2016, 9 pages.
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`Application Number 15349778
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`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
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`Art U .
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`mt
`I 1674
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`Not Yet Assigned
`I AVN-009DVCN6
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`IN FORMATION DISCLOSU RE
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